Excessive WorryNCT02331537
Internet-based Exposure Therapy for Excessive Worry
A study testing Internet-based cognitive-behavior therapy in people with Excessive Worry and Rumination, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Worry, Rumination
- What is being tested?
- Internet-based cognitive-behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- ≥ 18 years
- Situated in Sweden
- Informed consent
- Penn State Worry Questionnaire score more than 56 points
Who cannot join
- Substance dependence during the last six months
- Post traumatic stress disorder, bipolar disorder or psychosis
- Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
- MADRS-S score above 25 points
- Psychotropic medication changes within two months prior to treatment that could affect target symptoms.
- Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem.
Read the detailed description
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of excessive worry. The secondary objective is to a) investigate whether imagery based exposure is more effective than verbal exposure. b) investigate the cost-effectiveness of this treatment and c) to study if any variables could moderate/mediate the treatment outcome, such as metacognitions, degree of rumination or degree of depression.
Trial Design: Randomized controlled trial with waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in worry symptoms from baseline to Week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).
Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)
Safety Parameters: Adverse Events is assessed weekly via the internet.
Description of Trial Subjects: Patients > 18 years old with a PSWQ score more than 56 points
Number of Subjects: 140
- Conditions
- Excessive Worry, Rumination
- Being tested
- Internet-based cognitive-behavior therapy
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive-behavior therapyBehavioural
Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into seven modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive-behavior therapy | Experimental | The experimental group will go through active internet-based treatment. The treatment is 10 weeks long and is based on the principles of exposure i.e. the participant is instructed to stay with the frightening thought until it is no longer associated with anxiety. Receives: Behavioral: Internet-based cognitive-behavior therapy |
| Waitlist | No intervention | Waitlist control that will get the internet-based treatment when the first group has finished (i.e. Week 10). There are no active treatment for these participants at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire (PSWQ)
Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended
Secondary outcomes (8)
Meta Cognitions Questionnaire (MCQ-30)
Change in metacognitions from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Euroqol (EQ-5D)
Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Hospital anxiety and depression scale (HADS)
Change in anxiety and depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Spontaneous Use of Imagery Scale (SUIS)
Change in Spontaneous Use of Imagery from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Cognitive Avoidance Questionnaire (CAQ)
Change in cognitive avoidance from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Intolerance of Uncertainty Scale (IUS)
Change in tolerance of uncertainty from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive WorryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
- Investigators
- Erik M Andersson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331537
- Sponsor's protocol ID
- 2014-1944-31-5
- Status last verified
- Aug 2015
- First submitted
- 1 Jan 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02331537
- Acronym / sponsor ID
- 2014-1944-31-5
- Conditions
- Excessive Worry, Rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem.
Detailed description
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of excessive worry. The secondary objective is to a) investigate whether imagery based exposure is more effective than verbal exposure. b) investigate the cost-effectiveness of this treatment and c) to study if any variables could moderate/mediate the treatment outcome, such as metacognitions, degree of rumination or degree of depression.
Trial Design: Randomized controlled trial with waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in worry symptoms from baseline to Week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).
Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)
Safety Parameters: Adverse Events is assessed weekly via the internet.
Description of Trial Subjects: Patients > 18 years old with a PSWQ score more than 56 points
Number of Subjects: 140
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive-behavior therapy | Experimental | Behavioral: Internet-based cognitive-behavior therapyThe experimental group will go through active internet-based treatment. The treatment is 10 weeks long and is based on the principles of exposure i.e. the participant is instructed to stay with the frightening thought until it is no longer associated with anxiety. |
| Waitlist | No intervention | –Waitlist control that will get the internet-based treatment when the first group has finished (i.e. Week 10). There are no active treatment for these participants at all. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients
- ≥ 18 years
- Situated in Sweden
- Informed consent
- Penn State Worry Questionnaire score more than 56 points
Key exclusion criteria (6 listed)
- Substance dependence during the last six months
- Post traumatic stress disorder, bipolar disorder or psychosis
- Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
- MADRS-S score above 25 points
- Psychotropic medication changes within two months prior to treatment that could affect target symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive-behavior therapyInternet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into seven modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours. | Behavioural | Internet-based cognitive-behavior therapy |
Primary outcome
Penn State Worry Questionnaire (PSWQ)
Time frame: Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended
Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.
8 secondary outcomes
Meta Cognitions Questionnaire (MCQ-30)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Euroqol (EQ-5D)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Hospital anxiety and depression scale (HADS)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Spontaneous Use of Imagery Scale (SUIS)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Cognitive Avoidance Questionnaire (CAQ)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Intolerance of Uncertainty Scale (IUS)
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik M Andersson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive-behavior therapy in people with Excessive Worry and Rumination, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn State Worry Questionnaire (PSWQ) (time frame: Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015; AzTrials last refreshed its copy on 28 Oct 2026.